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orexin a other 2023-02-22 ClinicalTrials

Intermittent Theta Burst Stimulation for Narcolepsy-Related Depression: A Preliminary Study

Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation

Background

Narcolepsy, a chronic neurological condition characterized by overwhelming daytime sleepiness, often co-occurs with depression, significantly impacting patients' quality of life. Current treatments for comorbid depression in narcolepsy can have limited efficacy or undesirable side effects. This preliminary study addresses the critical need for novel, effective, and safe therapeutic options for depression in narcolepsy patients.

Study Design

Population
Patients with narcolepsy and comorbid depression.
Intervention
Intermittent Theta Burst Stimulation (iTBS) delivering 1800 pulses over 10 minutes per session.
Comparator
Sham control group.
Outcome
Change in validated depression scale scores.

Results

This study is designed to evaluate the efficacy and safety of iTBS as a treatment for comorbid depression in patients with narcolepsy. Researchers hypothesize that the active iTBS intervention will lead to a statistically significant reduction in depression severity compared to the sham control group. The primary outcome measure will be the change in validated depression scale scores, with secondary outcomes assessing improvements in sleep quality, narcolepsy-specific symptoms, and overall quality of life. The study aims to demonstrate a clinically meaningful improvement in the active treatment group, with each session delivering 1800 pulses over 10 minutes, establishing a robust therapeutic signal. The findings from this preliminary investigation are intended to inform and justify future larger-scale clinical trials.

Why It Matters

This research could provide a novel, non-invasive treatment option for the challenging comorbidity of depression in narcolepsy patients. If successful, iTBS could offer a well-tolerated alternative or adjunct to existing pharmacological treatments, potentially improving both mood and overall functional outcomes for these patients. Positive findings from this preliminary study would pave the way for larger Phase II or Phase III human clinical trials, bringing this promising therapy closer to clinical availability.


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Source: clinicaltrials:NCT05884112 · Ingested 2026-04-29 · Digest: gemini-2.5-flash